Tuesday, December 19,
2005
[EXPERIMENTAL DESIGN]
Vol. 9 No. 201
PUBLIC
HEALTH
* House OKs Drug
Maker Liability Safeguards
* The Age of Autism: The Story So Far
* Polluted Town Alarmed by Shortage of Sons
RESEARCH
* Oxygen Deprivation
May Contribute to Autism
COMMENTARY
* Immunizing The Drug-Makers
ACTION ALERT
From
the A-CHAMP Action Center
Take 11th Hour Action to
Prevent Drug Makers Martial Law Sneak Protection!
Go
Here |
House OKs Drug Maker
Liability Safeguards
By Kevin Freking for the Associated
Press.
http://tinyurl.com/belye
Drug manufacturers are a step closer
toward winning the liability protections they say they need before
investing in medicines to combat a bird flu pandemic.
Opponents
described the
protections,
approvedearly Monday by the House, as a
"massive Christmas bonus to the drug companies."
Consumers seeking
damages on claims
they were harmed by a
vaccine would have to prove willful misconduct on
the part of the drug manufacturers. That is a higher standard than
negligence, used in many product liability cases.
"Negligence is much easier to prove;
it's the failure to exercise
reasonable care," said Carl Tobias, a professor at the University of
Richmond School of Law. "Willful misconduct is a much higher standard.
You must intentionally misbehave. ... The high standard would clearly
discourage many suits." Senate Majority
Leader Bill Frist, R-Tenn. led the fight for the additional
protections. Amy Call, a Frist spokeswoman, said drug companies don't
view flu vaccine as profitable and won't get in the business if the
potential liabilities outweigh the potential benefits.
"When you're asking a company to come in
and develop something new that they won't make money off, ... there's
no reason for them to get into the market," Call said.
Frist attached the legislation to the
Defense Appropriations Bill, a bill viewed by lawmakers as must-pass
because it will fund military operations in Afghanistan and Iraq. The
Senate will take up the bill Wednesday or Thursday.
Democrats opposed attaching the
liability protections to the defense bill, as well as the substance of
the legislation.
"This liability shield can be granted to any product used
to prevent or treat an epidemic or a pandemic, and the secretary gets
to decide what that means. No court can review that decision," said
Rep. Henry Waxman, D-Calif. "But for those who may be injured,
Washington Republicans had only a lump of coal: a compensation program
without a single penny of funding."
Trial lawyers also attacked the
legislation.
"In the dead of night when no one was
watching, U.S. Senator Bill
Frist provided his corporate friends in the drug industry with an
unprecedented giveaway that puts the health and safety of Americans at
risk," said Ken Suggs, president of the Association of Trial Lawyers of
America.
"The trial lawyers apparently would
prefer to keep filing
frivolous lawsuits and collecting excessive attorney fees rather than
making sure public health is protected and injured parties are
compensated," Call replied.
Call said the legislation puts in place
a compensation system
modeled after what Congress approved for those who experience harmful
side effects from the smallpox vaccine. Under the program, pandemic flu
vaccine recipients or their families could apply for lost income,
medical expenses and death benefits.
But Democrats said the legislation
appropriates no money for the
compensation fund, and they question whether Republicans ever will fund
it.
The defense bill also sets aside $3.8
billion for improved
pandemic preparedness - but that's just slightly more than half of what
the president requested a few weeks ago.
Fears of a pandemic have increased in
recent months as a virus
infecting millions of birds has spread throughout Asia and parts of
Europe. While the virus has not yet appeared in the United States, or
spread from person to person, officials worry the bird flu could
eventually mutate and create a global health crisis because people have
no immunity to the virus.
Most of the funding, about $3.3 billion,
would go to the
Department of Health and Human Services, mostly for the purchase of
vaccines and antivirals, for state and local planning, and for improved
surveillance.
A spokesman for the department said the
appropriation was in line
with what the administration had planned on spending this year - even
though it's much less than what the president requested.
"It's a good start and we'll be back
next year to continue the work," said HHS spokeswoman Christina Pearson.
The Age of Autism: The Story So Far
Part 1 of 3
By Dan Olmsted for UPI
http://tinyurl.com/8qgwb
In February, we began
this ongoing series of articles on the roots and rise of autism. Now,
at the end of the year, here's a summary of our story so far:
-- Something happened among children
born in the early 1930s to bring autism to the attention of Leo Kanner,
the eminent and experienced Johns Hopkins University psychiatrist who
first described the disorder in a landmark 1943 paper. At the same
time, a Viennese pediatrician named Hans Asperger was noticing a
remarkably similar, though somewhat less severe, syndrome that came to
bear his name.
In our first column, "Donald T. and
Fritz V.," we found it amazing that these first two patients -- Donald
in the United States and Fritz in Austria -- were born within four
months of each other in 1933. Yet these
unique,
impossible-to-miss children with Autism Spectrum Disorders had been
around in similar numbers since the dawn of time?
Experts disagree, but our first and
still-tentative conclusion is
that's just plain unlikely. Scattered cases, sure. But 1 in 166, the
current U.S. autism rate in children? We don't see it.
-- Instead, it appears more likely
something happened around 1930
to set off the age of autism. Clearly, there are clues in the striking
commonalities among the first U.S. families stricken with the disorder.
They were college-educated; many had advanced degrees; four of the
fathers in the first 11 families identified by Kanner were medical
doctors -- psychiatrists, to be precise. There were professors,
lawyers, scientists, engineers. One mother was also a doctor, and all
of them were smart, accomplished women.
Some think that suggests a "geek
effect," in which gummed-up
genes finally find each other and generate offspring who aren't just
brainy and distracted, they're downright autistic. Based on our own
reporting, we don't buy that -- where were all the autistic offspring
of geeks before 1931, the year the oldest child ever diagnosed by
Kanner was born?
Coincidence or not, 1931 appears to be
the first year in which
U.S. vaccines
contained
a mercury
preservative called thimerosal, and
that yields an alternate hypothesis that could explain the decisive
increase in cases that we think is probable. Some parents and a
minority of scientists now believe thimerosal -- which is about half
ethyl mercury by weight -- is behind most autism cases, perhaps
triggering the disorder in a genetic subset of children who lack the
ability to excrete it.
Although it wasn't fully understood at
the time, organic mercury
is a potent neurotoxin in even minute quantities; beginning in 1999
thimerosal was phased out of routine childhood immunizations, though
federal health authorities say it is safe in that form, and they stand
by its continued use in flu shots for pregnant women and toddlers.
An alternative to the "geek theory" is
that those first 11
families back in the 1930s -- especially the ones with links to the
medical world -- would have had had the information, income and access
to take advantage of the latest health innovations and vaccinate
themselves and their children.
A related hypothesis was proposed to us
by Mark Blaxill, a
director of the anti-mercury-in-medicine group SafeMinds. He suggested
an association between several more of those first 11 cases and
ethyl-mercury-based fungicides that came on
the
market at the same
time, patented by the same scientist who developed thimerosal.
Case 1 in Kanner's study -- Donald T.,
born in 1933 -- came from
an area surrounded by a forest being replanted with seedlings by the
Civilian Conservation Corps.
Case 2's father was a plant pathologist.
Case 3's was a forestry
professor at a Southern university. Case 4's was a mining engineer.
Case 8's was a chemist-lawyer at the U.S. Patent Office. All of them
might have come in contact with mercury or other toxic compounds.
Given this intriguing though by no means
conclusive set of
associations, it's possible those parents were not in fact passing on
malignant mutations of the genes that made them doctors, forestry
professors, plant pathologists, chemists. Rather, through their
particular professions they might have exposed their children to
something wholly new in commercial medical and agricultural products,
something they did not know was devastatingly neurotoxic to developing
brains.
That might make the age of autism, in
effect, the age of organic mercury.
Not that it proves anything, but looking
back recently through
the groundbreaking book "Infantile Autism" by Bernard Rimland,
something struck us that we hadn't noticed before. This 1964 work is
widely credited with single-handedly
debunking the idea that
"refrigerator mothers" or aloof fathers caused autism.
Reviewing the rare descriptions of
children with autistic-type
behavior prior to Kanner's 1943 paper, Rimland noted a case that
"sounds very much like autism." That child's father, Rimland said, "was
a Ph.D."
A professor of chemistry.
That's the kind of detail that means
nothing to the experts
looking for incredibly complex gene interactions to explain autism, but
it makes our layman's hair stand on end.
As we pressed to find more about those
early cases, the trail led
all the way back to Case 1 himself, and to a small town in Mississippi.
We'll go there next.
E-mail: dolmsted@upi.com
NOTE: PART 2 of this series, "The Age of Autism: Missing
in Mississippi" is at this UPI link: http://tinyurl.com/7o79e
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Polluted Town Alarmed by Shortage of Sons
By Matt Crenson, AP http://tinyurl.com/9b38u
Aamjiwnaang First Nation, Canada -
Growing up with smokestacks on the horizon, Ada Lockridge never thought
much about the pollution that came out of them.
She never worried about the oil slicks
in Talfourd Creek, the acrid odors that wafted in on the shifting winds
or even the air-raid siren behind her house whose shrill wail meant "go
inside and shut the windows."
Now Lockridge worries all the time.
A budding environmental activist, she
recently made a simple but shocking discovery: There are two girls born
in her small community for every boy. A sex ratio so out of whack, say
scientific experts who helped her reveal the imbalance, almost
certainly indicates serious environmental contamination by one or more
harmful chemicals.
The question: Which ones? And another,
even more pressing question: What else are these pollutants doing to
the 850 members of this Chippewa community? Lockridge and her
neighbors
live just across the U.S.-Canada
border from Port
Huron, Mich., on the Aamjiwnaang First Nation Reserve. For nearly half
a century, their land has been almost completely surrounded by Canada's
largest concentration of petrochemical manufacturing.
Much of their original reserve, founded
in 1827, was sold out
from under them via questionable land deals in the 1960s. It is now
occupied by pipelines, factories and row upon row of petroleum storage
tanks.
The area is so dominated by the industry
that it is referred to on maps and in local parlance as "Chemical
Valley."
About two years ago, Suncor Energy -
which already operates a
refinery and petrochemical plant next to the Aamjiwnaang reserve -
proposed adding another factory to the mix, an ethanol plant to be
built on one of the few undeveloped parcels adjoining the community's
property.
Lockridge and other members of the band
joined to oppose the
plant. They asked biologist Michael Gilbertson to look at a binder full
of technical information about air, water and soil contamination on the
reserve.
In a conference call, he reported that
the data showed elevated
levels of dioxin, PCBs, pesticides and heavy metals including arsenic,
cadmium, lead and mercury.
Almost as an afterthought, he asked a question: Had anybody
noticed a difference in the number of girls and boys in the community?
At the other end of the line, the Aamjiwnaang and their allies were
suddenly abuzz.
"All of a sudden everybody in that room
started talking," said
Margaret Keith, a staffer for the Occupational Health Clinic for
Ontario Workers, a public health agency.
Somebody pointed out that the reserve
had fielded three girls'
baseball teams in a recent year and only one boys' team. Lockridge
thought about herself and her two sisters, with eight daughters among
them and only one son.
The question was not as offhand as it
seemed. "I had been
interested in sex ratio as an indicator - a very sensitive indicator of
effects going on as a result of exposure to chemicals," Gilbertson said
in a recent interview.
Gilbertson explained that certain
pollutants, including many
found on the Aamjiwnaang reserve, could interfere with the sex ratio of
newborns in a population. Heavy metals have been shown to affect sex
ratio by causing the miscarriage of male fetuses. Other pollutants
known as endocrine disrupters - including dioxin and PCBs - can wreak
all sorts of havoc by interfering with
the
hormones that determine
whether a couple will have a boy or a girl.
If some pollutant was skewing the
distribution of girls and boys
in her family and her community, Ada Lockridge thought, what else could
it be doing? Statistics indicate that one in four Aamjiwnaang children
has behavioral or learning disabilities, and that they suffer from
asthma at nearly three times the national rate. Four of 10 women on the
reserve have had at least one miscarriage or stillbirth.
"I was throwing up thinking about what
was in me," said Lockridge, who is 42. "I cried. And then I got angry."
She got a copy of the band membership
list, and tallied the
number of boys and girls born in each year since 1984. Sure enough, the
percentage of boys started dropping below 50 percent around 1993. It is
now approaching 30 percent, with no sign of leveling off.
+ Full report here: http://tinyurl.com/9b38u
RESEARCH
Oxygen
Deprivation May Contribute to Autism
By Randy Dotinga http://tinyurl.com/asree
HealthDay News - New research with rats
suggests that oxygen deprivation during birth could be a contributing
cause of autism.
There's no easy way to test the
oxygen-deprivation theory in humans, and the finding isn't likely to
lead to better treatments in the near future. Still, the research gives
scientists greater insight into how factors other than genetics may
play a role in autism, said Fabrizio Strata, a neuroscience researcher
at the University of California, San Francisco and co-author of the
study.
Symptoms of autism, the most common
condition in a group of developmental disorders known as autism
spectrum disorders, can range from mild to severe. The disability
usually strikes by age 3. It lasts a lifetime, and there is no cure,
although some people with autism can learn to function well.
According to the U.S. Centers for
Disease Control and Prevention, autism ischaracterized
by three distinctive behaviors. Autistic children
have difficulties with social interaction, display problems with verbal
and nonverbal communication, and exhibit repetitive behaviors or
narrow, obsessive interests. Scientists are not certain what causes
autism, but it is likely that both genetics and environment play a role.
For reasons that aren't clear, autism
seems to have become more
common in recent years. One hotly debated theory suggests that vaccines
are responsible, although some studies have failed to find a link.
Oxygen deprivation during birth is
considered one possible cause because it can lead to brain damage.
By boosting the level of nitrogen in the
air, Strata and
colleagues deprived rat pups of normal levels of oxygen for as long as
10 to 12 minutes during birth. When the rats grew older, they displayed
symptoms similar to those found in autistic children. It took longer
for the rats to respond to some sounds, for example, and the brain
regions that handle sound were disrupted.
Why would a baby be oxygen-deprived in
the first place? According
to Strata, a complicated labor can cut off a newborn's oxygen supply,
as can a twisted umbilical cord.
Andy Shih, chief science officer with the National Alliance for
Autism Research, said the oxygen-deprivation study presents an
"interesting hypothesis," although the research hasn't been confirmed
in humans.
It's possible that future research could
lead to changes in
obstetric practices to minimize the chance that babies will go without
oxygen, Shih said. But "we're far away from that at this point."
The study findings appear in the Dec.
19-24 issue of the Proceedings of the National Academy of Sciences.
Brief commentary: this is a stillborn
hypothesis absent reports of epidemics of twisted umbilical cords and
complicated labors to account for the subsequent present epidemic of
autism. - LS
EVIDENCE
OF HARM
DISCUSSION
LIST
HEATS UP
AS MERCURY LINK TO AUTISM QUESTION SPREADS
An Evidence of Harm email discussion list has
been created in response to the growing interest in the book and
the issues it chronicles. Now 1,200 subscribers. Here is how to
subscribe (no cost): EOHarm-subscribe
COMMENTARY
Immunizing The Drug-Makers
From the
Milwaukee Journal Sentinel .
http://tinyurl.com/c8usf
The House ostensibly took steps early
Monday to protect Americans
from a bird flu epidemic, but the people who were really being
protected are the vaccine-makers. And unless the Senate rejects the
House action, which it is expected to consider later this week,
Congress will have given big business an immunization - against civil
lawsuits by patients injured by flu vaccines.
That's both wrong and unnecessary.
As one of the riders on the defense
appropriations bill, the
House Monday granted sweeping legal immunity to companies that produce
vaccines in response to a potentially deadly flu pandemic. Those
pushing for such immunity, including President Bush and Senate Majority
Leader Bill Frist (R-Tenn.), say the protection is needed to convince
vaccine-makers to start making influenza vaccine, especially with the
looming threat of bird flu.
While that may seem reasonable - and
even responsible from a
public health standpoint - it doesn't reflect economic reality.
Yes, as Bush and Frist say, there has
been a disturbing and
steady retreat by American companies from the vaccine business over the
past 20 years. But the reason, consumer advocates legitimately argue,
isn't so much the concern about liability.
This was borne out by a study by two
professors in the Harvard
University School of Public Health, published in a recent issue of the
Journal of the American Medical Association. The professors concluded
that low profits and unpredictable demand, not litigation, were the
primary reasons drug companies had been pulling out of the vaccine
business. Last year, Anthony Fauci, the highly respected chief of
infectious disease for the National Institutes of Health, essentially
told The Associated Press the same thing.
What's more, some companies, including
Sanofi Pasteur, the
largest supplier of flu vaccine to the United States, have already
started working on avian flu vaccines, even though there is no sweeping
immunity currently in place in the U.S.
While it's reasonable to have some
liability protections in place
for drug companies against frivolous lawsuits, consumer advocates,
including the Center for
Justice and
Democracy, argue convincingly
that
this legal shield, which
would get triggered by a declaration of
emergency from the secretary of health and human services, amounts to
blanket immunity. Injured parties would have to prove that the
companies engaged in "willful" misconduct or neglect - an exceedingly
difficult task.
The measure would have even more ominous
implications for
consumers because the protections could be extended not just to
vaccines but to other products, even over-the-counter medications, in
an epidemic.
In short, this is bad medicine. And when
it gets its chance, the Senate should spit it out.
ACTION ALERT
From
the A-CHAMP Action Center
Take Action!
Frist Gives
Parents the
Slip Again;
Leadership in
Congress Muscles Drug Company Liability Provision into Unrelated
Defense Bill
Bill
Gives Immunity to
Pharma;
Also Preempts State Laws
Banning Thimer
In the
middle of the night, Senator Frist used raw
political muscle to impose sweeping, never-before-seen immunity for
drug companies into the Department of Defense Appropriations Conference
Report. The language constitutes an unprecedented wish-list of
liability protections that will allow the industry to recklessly injure
or kill Americans with contaminated drugs and vaccines and never be
held accountable. This language offers more special interest
immunity than any bill ever considered by either body of the Congress.
You can read the provision by going here
http://tinyurl.com/8l3sy
and
downloading a pdf.
The
language also would allow preemption of state laws
providing for safe vaccines, such as laws banning mercury in vaccines.
If the President or his admininistration say so this law would allow
the production of vaccines containing mercury even if your state has a
law banning it. The people who backed this legislation have no respect
for states like California, Iowa, Illinois, Delaware, Missouri and New
York, whose citizens have sent a clear message: KEEP MERCURY OUT OF
VACCINES.
Below
is a list of the key provisions in this bill. If
any of them bother you TAKE ACTION, send a letter, or fax or use A-CHAMP's
email messaging system. Use our sample letter or write your own.
http://capwiz.com/a-champ/issues/alert/?alertid=8328971&type=ML
You can
find your Senator's contact information here:
http://capwiz.com/a-champ/dbq/officials/
We
especially need our Republican parents and friends to
write their Senators. Without the critical support of key Republican
Senators the Eli Lilly Rider, immunity legislation that was enacted in
2002, would never have been repealed. (Thank you Senators Collins,
Snowe and Chafee, among others).
Key
Provisions of the immunity provisions in HR 2863
that will be considered by the Senate this week (Senate number is not
assigned yet).
Take Action! http://tinyurl.com/8l3sy
Six
objectionable things that the new immunity
legislation will do:
1)
Allows use of Thimerosal in vaccines:
If the Secretary of Health and Human Services designates that a vaccine
is a "covered countermeasure" thimerosal can be used in the
vaccine, even if your state has banned Thimerosal. Any state
legislation covering vaccines would be rendered ineffective and Federal
law would preempt all state provisions.
2)
Immunity for ALL Drugs and Vaccines:
The language could potentially apply to any drug, vaccine, or
biological product that the Secretary of HHS deems a “covered
countermeasure.” This list could include any commercial drug like
Tylenol and is not limited in any way to drugs or vaccines meant to
treat a pandemic like avian flu.
3) Immunity at ANY Time:
The immunity language depends on the Secretary making a declaration
that a health condition is causing a public health emergency or that
some health
condition could
become
an emergency at some point in the
future. There is nothing that limits this declaration to an
actual health emergency or to an actual pandemic illness. This
declaration could occur at any time for almost any reason.
4) Immunity for Harm
Caused by a Manufacturer’s Bad Conduct:
The immunity applies no matter what the drug company did wrong.
Even if a drug company operates a dirty facility in which a batch of
vaccines is contaminated, and that vaccine kills thousands of
Americans, the drug company is immune from liability.
5) Immunity for Anything but Assault or Murder:
The language explicitly protects drug companies who act recklessly or
who are grossly negligent, and would allow a claim to go forward only
where a drug company acted with such willful misconduct as to
constitute criminal assault or murder. Anything less than
criminal conduct is protected.
6) Immunity for Murder unless the Secretary or the Attorney General Say
Otherwise:
Even if a drug company has acted with “willful misconduct” as defined
by this language, the drug company is still immune from accountability
unless the Secretary or the Attorney General initiates an enforcement
action against the drug company and that action is pending at the time
a claim is filed or
the action
resulted in some
form of punishment. So
even if a drug company knowingly kills thousands of people, if no
official enforcement action is taken, that company is still
immune.
Take Action to Stop this Outrageous Legislation!
http://tinyurl.com/8l3sy
Or go here
to find your Senators telephone or fax number - call and fax!
http://capwiz.com/a-champ/dbq/officials/
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